Massive west african trial takes on deadly lassa fever with new drug cocktail
NCT ID NCT06212336
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This large clinical trial in West Africa is testing several drugs—including favipiravir, ribavirin, dexamethasone, and a new drug called ARN-75039—to find a better treatment for Lassa fever, a viral disease that kills thousands each year. The study will enroll about 1,755 hospitalized patients and measure whether these drugs reduce death and organ failure compared to standard care. The goal is to find a safer and more effective option than the current treatment, ribavirin, which has serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Favipiravir, Ribavirin, Dexamethasone, ARN-75039
- What this could lead to
- If successful, this trial could identify a safer and more effective treatment for Lassa fever, potentially saving thousands of lives in West Africa.
- What could go wrong
- This is an early-to-mid stage trial, and the drugs may not prove more effective than current care. Ribavirin has known toxicity, and new drugs like ARN-75039 are still being tested for safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 1,755 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1. General Inclusion criteria * Clinical disease with signs and symptoms suggestive for LF * Positive plasma LASV RT-PCR * Participant requires hospitalization per the local guidelines * Participant or their legally authorized representative is able and willing to sign the informed consent Exclusion criteria * Unwilling to provide informed consent * Positive pregnancy test * Unwilling to provide informed consent * History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document * Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion * Has received a vaccine against LF 2. Sub-protocols 2.1 Favipiravir high dose sub-protocol Inclusion criteria • Age ≥ 18 years old Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) * Treatment contraindicated with favipiravir according to the Reference safety document * Pre-existing liver failure * Severe symptomatic gout/hyperuricemia * History of QT prolongation or arrhythmia or other cardiac disorders * PR interval ≥ 200 ms * Hypersensitivity to excipients * Inability to take oral drug (e.g. encephalopathy, severe vomiting) 2.2. Favipiravir-Ribavirin sub-protocol Inclusion criteria • Age ≥ 18 years old Exclusion criteria * Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) * Treatment contraindicated with favipiravir according to the Reference safety document * Pre-existing liver failure * Severe symptomatic gout/hyperuricemia * History of QT prolongation or arrhythmia or other cardiac disorders * PR interval ≥ 200 ms * Hypersensitivity to excipients * Inability to take oral drug (e.g. encephalopathy, severe vomiting) 2.3. Dexamethasone sub-protocol Inclusion criteria • Age ≥ 12 years old Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential) • Known intolerance and contra-indications to ribavirin or dexamethasone • Patients who already received a corticosteroid within the preceding 7 days 2.4 ARN-75039 subprotocols Exclusion criteria • History of severe gastrointestinal disease • History of chronic generalized pruritus * History of severe chronic liver disease * History of severe cardiac disorder
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abubakar Tafawa Balewa University Teaching Hospital
NOT_YET_RECRUITINGBauchi, Nigeria
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Federal Medical Center Owo
RECRUITINGOwo, Ondo State, Nigeria
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Irrua Specialist Teaching Hospital
RECRUITINGIrrua, Edo, Nigeria
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Phebe Hospital
NOT_YET_RECRUITINGSuacoco, Bong County, Liberia
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